Thursday, May 12, 2011
HeLa, HIPAA and the ethics of informed consent
Recently I read the book The Immortal Life of Henrietta Lacks by Rebecca Skloot. This book is a must-read for anyone involved in medical research. The book tells the story of a woman, Henrietta Lacks, and her family. Ms. Lacks was treated for cervical cancer at John's Hopkins in 1951. Her malignant cervical cells (HeLa) were harvested and disseminated to become the first "immortal" cell line widely used for scientific research, including their use in the development of the polio vaccine. The story details what occurred in the aftermath of Ms. Lacks' death to her family, a poor African-American family living in Maryland--a family, which in today's lingo, had very poor "health literacy." The account brings up key ethical issues of biomedical research that were evolving during that era.
The story of the HeLa cells began after the Nuremberg trials of World War II, which involved experimentation on concentration camp prisoners of the Holocaust and the eventual Nuremberg Code and World Medical Association's Declaration of Helsinki in 1964, which described a code of ethics for research involving human subjects.
At the time of Henrietta Lacks, the concept of informed consent was still in its infancy. Institutions, such as John's Hopkins, where Ms. Lacks received her care, did not have Institutional Review Boards (IRBs) to govern and approve their research protocols. The events of the Lacks family took place in the same era as the "Tuskegee Experiment" (1932-1974), conducted by the U.S. Public Health Service. Tuskegee gained notoriety by studying the natural history of untreated syphilis in poor African-American sharecroppers in Tuskegee, Alabama. Its participants were led to believe that they were receiving syphilis treatment from the Public Health Service, when in fact the treatment (penicillin) was being withheld for the sake of research.
Nuremberg and Tuskegee shaped the precedent for federal regulation of biomedical research involving human subjects with the creation of the Belmont Report in 1979, which describes the core ethical principles that must be met in conducting biomedical research on human subject. At this time federal regulation was enacted calling for the implementation of IRBs to oversee human subject research in all institutions involved in conducting research. Those of us who have participated in research at academic institutions should be well aware of this history, which we all review in our IRB certification process.
What is interesting to me about the Henrietta Lacks story is comparing the evolution of biomedical research ethics in that era (1940s-70s) with the ethical dilemmas that face us today. At the time of HeLa cell dissemination, informed consent was at the forefront of discussion, whereas in our current era we have struggled with two core elements of ethics in biomedical research: privacy and managing conflicts of interest. In 1996, the HIPAA privacy rule was enacted establishing nationwide security standards and safeguards for the use of electronic health care information as well as the creation of privacy standards for protected health information. HIPAA went through various iterations prior to its evolution into its current version issued in 2002. Similar to the response that occurred in reaction to federal policy outlining requirements for informed consent, researchers of today have oft complained that HIPAA has been an impediment to scientific progress and research. The latest HIPAA debate has revolved around federal requirements that medical providers and insurers notify patients in the event of discovering a privacy breech. Multiple examples of such privacy breaches have been described in the media ranging from stolen laptops to identity theft. Interestingly, in 2010 a health plan, Cignet Health, in Maryland was sued over non-compliance with HIPAA and fined a monetary penalty of $4.3 million dollars. However, the suit was not over a breach of confidentiality; rather, it was over Cignet's refusal to allow 41 of their patients access to their own medical records.
In addition to sorting out privacy at is relates to biomedical research, medical care, and electronic communications, the other core ethical issue defining our era is conflict of interest. In 2008, Sen. Charles Grassley, (R-Iowa) brought to light conflicts of interest that were prevalent in the world of psychiatry. At the time, according to Grassley's investigation, 30% of funding for the American Psychiatric Association, the premier professional organization in the field of psychiatry, came from the pharmaceutical industry. What followed suit was an unveiling of pharmaceutical ties that were reported to contaminate the thought leaders of many research institutions in all fields of medicine.
My own institutional affiliate was not immune and in 2008 Charles Nemeroff, renowned researcher in psychiatry and chair of the Department of Psychiatry at Emory University gave up his title and eventually left Emory after being investigating by Grassley. Academicians can attest to the changes that have occurred in the past several years with respect to disclosures of financial interest in research centers. Is it a witch-hunt, or is the cleansing of these relationships based in true ethical conflict? After all, isn't conflict of interest inherent in all of business?
The story of Henrietta Lacks was interesting from a historical perspective. It took decades to sort through informed consent. In contrast, the debates over health privacy and conflict of interest are still in their infancy. The fact that remains similar, however, is that the underprivileged, and medically "illiterate" are far more likely to be the subject of ethical violations than others, even in today's era. In the case of the Lacks family, poor communication and lack of confidence on the part of the medical establishment that the family would be able to grasp the content of the discussion resulted in a lack of informed consent. Today, who is more likely to be de-identified appropriately in a medical blog, a Hispanic patient at a county hospital, or a wealthy business executive? No wonder the underprivileged are often suspicious of traditional medicine.
Juliet K. Mavromatis, FACP, is a primary care physician in Atlanta, Ga. Previous to her primary care practice, she served on the general internal medicine faculty of Emory University, where she practiced clinical medicine and taught internal medicine residents for 12 years, and led initiatives to improve the quality of care for patients with diabetes. This work fostered an interest in innovative models of primary care delivery. Her blog, DrDialogue, acts as a conversation about health topics for patients and health professionals. This post originally appeared there.
Labels: ethics
posted by Juliet Mavromatis at
11:00 AM
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Members of the American College of Physicians contribute posts from their own sites to ACP Internistand ACP Hospitalist. Contributors include:
Albert Fuchs,
MD
Albert Fuchs, MD, FACP, graduated from the
University of California, Los Angeles School of Medicine, where he
also did his internal medicine training. Certified by the American
Board of Internal Medicine, Dr. Fuchs spent three years as a
full-time faculty member at UCLA School of Medicine before opening
his private practice in Beverly Hills in 2000.
And Thus, It Begins
Amanda Xi, ACP Medical
Student Member, is a first-year medical student at the OUWB School
of Medicine, charter class of 2015, in Rochester, Mich., from which
she which chronicles her journey through medical training from day
1 of medical school.
Zackary Berger
Zackary Berger, MD, ACP Member, is a primary care doctor and
general internist in the Division of General Internal Medicine at
Johns Hopkins. His research interests include doctor-patient
communication, bioethics, and systematic reviews.
Controversies in Hospital
Infection Prevention
Run by three ACP
Fellows, this blog ponders vexing issues in infection prevention
and control, inside and outside the hospital. Daniel J Diekema, MD,
FACP, practices infectious diseases, clinical microbiology, and
hospital epidemiology in Iowa City, Iowa, splitting time between
seeing patients with infectious diseases, diagnosing infections in
the microbiology laboratory, and trying to prevent infections in
the hospital. Michael B. Edmond, MD, FACP, is a hospital
epidemiologist in Richmond, Va., with a focus on understanding why
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settings. Eli N. Perencevich, MD, ACP Member, is an infectious
disease physician and epidemiologist in Iowa City, Iowa, who
studies methods to halt the spread of resistant bacteria in our
hospitals (including novel ways to get everyone to wash their
hands).
db's Medical Rants
Robert M. Centor, MD, FACP, contributes short essays contemplating
medicine and the health care system.
DrDialogue
Juliet K. Mavromatis, MD, FACP, provides a conversation about
health topics for patients and health professionals.
Dr. Mintz' Blog
Matthew Mintz, MD, FACP, has practiced internal medicine for more
than a decade and is an Associate Professor of Medicine at an
academic medical center on the East Coast. His time is split
between teaching medical students and residents, and caring for
patients.
Everything
Health
Toni Brayer, MD, FACP, blogs about the rapid changes in science,
medicine, health and healing in the 21st century.
FutureDocs
Vineet Arora, MD, FACP, is Associate Program Director for the
Internal Medicine Residency and Assistant Dean of Scholarship &
Discovery at the Pritzker School of Medicine for the University of
Chicago. Her education and research focus is on resident duty
hours, patient handoffs, medical professionalism, and quality of
hospital care. She is also an academic hospitalist.
Glass Hospital
John H. Schumann, MD, FACP, provides transparency on the workings
of medical practice and the complexities of hospital care,
illuminates the emotional and cognitive aspects of caregiving and
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physician, and offers behind-the-scenes portraits of hospital
sanctums and the people who inhabit them.
Gut Check
Ryan Madanick, MD, ACP Member, is a gastroenterologist at the
University of North Carolina School of Medicine, and the Program
Director for the GI & Hepatology Fellowship Program. He
specializes in diseases of the esophagus, with a strong interest in
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I'm dok
Mike Aref, MD, PhD, FACP, is an academic hospitalist with an
interest in basic and clinical science and education, with
interests in noninvasive monitoring and diagnostic testing using
novel bedside imaging modalities, diagnostic reasoning, medical
informatics, new medical education modalities, pre-code/code
management, palliative care, patient-physician communication,
quality improvement, and quantitative biomedical imaging.
Informatics
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William Hersh, MD, FACP, Professor and Chair, Department of Medical
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David Katz, MD
David L. Katz, MD, MPH, FACP, is an internationally renowned
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Just Oncology
Richard Just, MD, ACP Member, has 36 years in clinical practice of
hematology and medical oncology. His blog is a joint publication
with Gregg Masters, MPH.
KevinMD
Kevin Pho, MD, ACP Member, offers one of the Web's definitive sites
for influential health commentary.
MD
Whistleblower
Michael Kirsch, MD, FACP, addresses the joys and challenges of
medical practice, including controversies in the doctor-patient
relationship, medical ethics and measuring medical quality. When
he's not writing, he's performing colonoscopies.
Medical Lessons
Elaine Schattner, MD, FACP, shares her ideas on education, ethics
in medicine, health care news and culture. Her views on medicine
are informed by her past experiences in caring for patients, as a
researcher in cancer immunology, and as a patient who's had breast
cancer.
Mired in MedEd
Alexander M.
Djuricich, MD, FACP, is the Associate Dean for Continuing Medical
Education (CME), and a Program Director in Medicine-Pediatrics at
the Indiana University School of Medicine in Indianapolis, where he
blogs about medical education.
More Musings
Rob Lamberts, MD, ACP Member, a med-peds and general practice
internist, returns with "volume 2" of his personal musings about
medicine, life, armadillos and Sasquatch at More Musings (of a
Distractible Kind).
Prescriptions
David M. Sack, MD, FACP, practices general gastroenterology at a
small community hospital in Connecticut. His blog is a series of
musings on medicine, medical care, the health care system and
medical ethics, in no particular order.
Reflections of a Grady
Doctor
Kimberly Manning, MD, FACP, reflects on the personal side of being
a doctor in a community hospital in Atlanta.
The Blog of Paul Sufka
Paul Sufka,
MD, ACP Member, is a board certified rheumatologist in St. Paul,
Minn. He was a chief resident in internal medicine with the
University of Minnesota and then completed his fellowship training
in rheumatology in June 2011 at the University of Minnesota
Department of Rheumatology. His interests include the use of
technology in medicine.
Technology in (Medical)
Education
Neil Mehta, MBBS, MS, FACP, is interested in use of technology in
education, social media and networking, practice management and
evidence-based medicine tools, personal information and knowledge
management.
Peter A. Lipson,
MD
Peter A. Lipson, MD, ACP Member, is a practicing internist and
teaching physician in Southeast Michigan. The blog, which has been
around in various forms since 2007, offers musings on the
intersection of science, medicine, and culture.
Why is American Health Care So Expensive?
Janice
Boughton, MD, FACP, practiced internal medicine for 20 years before
adopting a career in hospital and primary care medicine as a locum
tenens physician. She lives in Idaho when not traveling.
World's Best Site
Daniel Ginsberg, MD,
FACP, is an internal medicine physician who has avidly applied
computers to medicine since 1986, when he first wrote medically
oriented computer programs. He is in practice in Tacoma,
Washington.
Other blogs of note:
American Journal of
Medicine
Also known as the Green Journal, the American Journal of Medicine
publishes original clinical articles of interest to physicians in
internal medicine and its subspecialities, both in academia and
community-based practice.
Clinical
Correlations
A collaborative medical blog started by Neil Shapiro, MD, ACP
Member, associate program director at New York University Medical
Center's internal medicine residency program. Faculty, residents
and students contribute case studies, mystery quizzes, news,
commentary and more.
Interact MD
Michael Benjamin, MD, ACP member, doesn't accept industry money so
he can create an independent, clinician-reviewed space on the
Internet for physicians to report and comment on the medical news
of the day.
PLoS Blog
The Public Library of Science's open access materials include a
blog.
White Coat
Rants
One of the most popular anonymous blogs written by an emergency
room physician.
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